Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

NCT05399485 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: BHV3000-309C4951021
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 44

Brief Summary

This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

Conditions

Migraine

Keywords

Migraine; Headache; Migraine Prevention

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase

  Migraine day: 1) day of electronic diary (eDiary) efficacy data with a qualified migraine headache, defined as: Headache lasted for \>= 30 minutes and had 2 or more of following pain features: Unilateral and pulsating, moderate or severe pain intensity, worsen or avoid physical activity with one or more of the following associated symptoms: nausea, vomiting, both photophobia and phonophobia or 2) Acute migraine-specific medication day as eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or non-scheduled OL Rimegepant dosing day. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month \[Week 9 to 12\])/ (total number of efficacy data days in month \[Week 9 to 12\]).

  Baseline, Week 9 to Week 12 of the DBT phase

Secondary Outcomes (25)

• Percentage of Participants With at Least 50% Reduction From Baseline in the Mean Number of Moderate to Severe Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase

  Baseline, Week 9 to Week 12 of the DBT phase

• Mean Change From Baseline in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)

  Baseline, Week 1 to Week 12 of the DBT phase

• Mean Change From Baseline in Number of Migraine Days Per Month From Week 1 to 4 of the DBT Phase

  Baseline, Week 1 to Week 4 of the DBT phase

• Mean Number of Acute Migraine-specific Medication Days Per Month From Week 9 to 12 of the DBT Phase

  Week 9 to Week 12 of the DBT phase

• Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) v 2.1 Role Function - Restrictive Domain Score at Week 12 of the DBT Phase

  Baseline, Week 12 of the DBT phase

Study Arms (2)

Rimegepant

EXPERIMENTAL

Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12

Drug: Rimegepant

Placebo

PLACEBO COMPARATOR

Randomization Phase: one matching placebo every other day until week 12

Drug: Placebo

Interventions

Rimegepant DRUG

Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12

Also known as: BHV3000

Rimegepant

Placebo DRUG

Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
• Age of onset of migraines prior to 50 years of age.
• Migraine attacks, on average, lasting 4 to 72 hours if untreated.
• Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol).
• or more migraine days during Observation Period.
• Not more than 18 headache days during the Observation Period.
• Ability to distinguish migraine attacks from tension/cluster headaches.
• Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and the dose is not expected to change during the course of the study.
• Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

You may not qualify if:

• Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine.
• Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.
• History of systemic use of analgesics (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
• Subject with a history of HIV disease.
• Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
• Uncontrolled hypertension, or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for 3 months prior to screening).
• Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
• Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption.
• The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
• History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
• Participation in any other investigational clinical trial while participating in this clinical trial.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Medical Corporation Seikokai Takanoko Hospital

Matsuyama, Ehime, 790-0925, Japan

Location

Jinnouchi Neurosurgical Clinic

Kasuga-shi, Fukuoka, 816-0802, Japan

Location

Ikeda Neurosurgical Clinic

Kasuga-shi, Fukuoka, 816-0824, Japan

Location

SUBARU Health Insurance Society Ota Memorial Hospital

Ota-shi, Gunma, 373-8585, Japan

Location

Doi Clinic Internal Medicine/Neurology

Hiroshima, Hiroshima, 730-0031, Japan

Location

Japanese Red Cross Asahikawa Hospital

Asahikawa-shi, Hokkaido, 070-8530, Japan

Location

Nakamura Memorial Hospital

Chūōku, Hokkaido, 060-8570, Japan

Location

Higashi Sapporo Neurology and Neurosurgery Clinic

Sapporo, Hokkaido, 003-0003, Japan

Location

Konan Medical Center

Higashinada-ku, Hyōgo, 658-0064, Japan

Location

Nishinomiya Munic. Ctr. Hosp.

Nishinomiya-shi, Hyōgo, 663-8014, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, 310-0015, Japan

Location

Kijima Neurosurgery Clinic

Kahoku-gun, Ishikawa-ken, 929-0342, Japan

Location

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-8505, Japan

Location

Atsuchi Neurosurgery Hospital

Kagoshima, Kagoshima-ken, 892-0842, Japan

Location

Tanaka Neurosurgical Clinic

Kagoshima, Kagoshima-ken, 892-0844, Japan

Location

St. Marianna Univ. Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Fujitsu Clinic

Nakahara, Kanagawa, 211-8588, Japan

Location

Atago Hospital

Kochi, Kochi, 780-0051, Japan

Location

Umenotsuji Clinic

Kochi, Kochi, 780-8011, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, 861- 4193, Japan

Location

Tatsuoka Neurology Clinic

Kyoto, Kyoto, 600-8811, Japan

Location

Sendai Headache and Neurology Clinic, Medical Corporation

Sendai, Miyagi, 982-0014, Japan

Location

Ooba Clinic for Neurosurgery & Headache

Ōita, Oita Prefecture, 870-0831, Japan

Location

Makabe Clinic

Okayama, Okayama-ken, 700-0964, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, Okayama-ken, 700-8557, Japan

Location

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka, Osaka, 530-8480, Japan

Location

Tominaga Clinic

Osaka, Osaka, 556-0015, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Takase Intern. Med. Clinic

Toyonaka-shi, Osaka, 560-0012, Japan

Location

Saitama Medical University Hospital

Iruma-gun, Saitama, 350-0495, Japan

Location

Saitama Neuropsychiatric Institute

Saitama-shi, Saitama, 338-8577, Japan

Location

Japanese Red Cross Shizuoka Hospital

Shizuoka, Shizuoka, 420-0853, Japan

Location

Dokkyo Medical Univ. Hosp.

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokai univ. hachioji hosp.

Hachioji-shi, Tokyo, 192-0032, Japan

Location

Shinagawa Strings Clinic

Minato-ku, Tokyo, 108-0075, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

USUDA CLINIC for internal medicine

Setagaya-ku, Tokyo, 156-0043, Japan

Location

Fukuuchi Pain Clinic

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Nishiogi Pain Clinic

Suginami-ku, Tokyo, 167-0054, Japan

Location

Sakura Neuro Clinic

Toyama, Toyama, 930-0803, Japan

Location

Nagamitsu Clinic

Hofu-shi, Yamaguchi, 747-0802, Japan

Location

Nagaseki Headache Clinic

Kai-shi, Yamanashi, 400-0124, Japan

Location

Related Publications (1)

• Kitamura S, Matsumori Y, Yamamoto T, Ishikawa T, Hoshino Y, Yoshimatsu H, Thiry A, Arakawa A, Croop R, Fullerton T, Sakai F, Takeshima T. Efficacy and safety of rimegepant for the preventive treatment of migraine in Japan: A double-blind, randomized controlled trial. Headache. 2025 Sep;65(8):1403-1412. doi: 10.1111/head.14995. Epub 2025 Jun 20.

  PMID: 40542538 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: August 9, 2022
• Primary Completion: January 18, 2024
• Study Completion: November 7, 2024
• Last Updated: November 18, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (44)